Study Evaluating the Efficacy and Safety of JCAR015 in Adult B-cell Acute Lymphoblastic Leukemia (B-ALL)

Stopped early · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia

In brief

This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that express the CD19 protein on the cell surface. The study will determine if these modified T cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this treatment on survival.

Key facts

Study ID: NCT02535364
Run by: Juno Therapeutics, a Subsidiary of Celgene
People needed: 82
Starts: 2015-08-21
Expected to finish: 2017-09-01
Last updated by the study team: 2020-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years at the time of consent
Relapsed or refractory B-ALL, defined as:
First or greater bone marrow relapse from CR, or
Any bone marrow relapse after allogeneic hematopoietic stem cell transplant (HSCT); subjects must be at least 100 days from HSCT at the time of screening and off immunosuppressant medication for at least 1 month at the time of screening, and have no active graft-vs-host disease (GVHD), or
Refractory B-ALL, defined by not having achieved a CR or CRi after two attempts at remission induction using standard regimens, or
Ph+ B-ALL if subjects are intolerant to or ineligible for tyrosine kinase inhibitor (TKI) therapy, or have progressed after at least one line of TKI therapy
Morphological evidence of disease in bone marrow (at least 5% blasts)
Evidence of CD19 expression
Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2 at the time of screening
Adequate pulmonary, renal, hepatic, and cardiac function
Adequate central or peripheral vascular access for leukapheresis procedure

You may not qualify if…

Isolated extramedullary disease relapse
Concomitant genetic syndrome or other known bone marrow failure syndrome
Burkitt's lymphoma/leukemia or chronic myelogenous leukemia lymphoid blast crisis (p210 BCR-ABL+)
Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before screening
Prior treatment with any gene therapy product
Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening
Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
Active central nervous system (CNS) involvement by malignancy (defined as CNS-3 per National Comprehensive Cancer Network [NCCN] guidelines)
History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Participation in an investigational research study using an investigational agent within 30 days of screening
History of treatment with a murine-derived biological product other than blinatumomab unless subject has been shown to be negative for human-anti-mouse-antibodies (HAMA) prior to or during screening
Pregnant or nursing women
Use of prohibited medications:
Steroids: Therapeutic doses of corticosteroids are prohibited within 7 days prior to leukapheresis.
Allogeneic cellular therapy: Donor lymphocyte infusions (DLI) are prohibited within 4 weeks prior to leukapheresis
GVHD therapies: Any drug used for GVHD within 4 weeks prior to leukapheresis
Chemotherapies: Salvage chemotherapy must be stopped at least 1 week prior to leukapheresis
Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis

Where it is running

University of Alabama Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
City of Hope — Duarte, California, United States
University of California — San Francisco, California, United States
University of Colorado Denver -- Anschutz Medical Campus — Aurora, Colorado, United States
Sylvester Comprehensive Cancer Center/UMHC — Miami, Florida, United States
The Blood and Marrow Transplant Program at Northside Hospital — Atlanta, Georgia, United States
Northwestern University Robert H Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
University of Chicago Medical Center — Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Washington University School of Medicine — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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